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Article(id=1322609113813594537, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1322609030938346427, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202506149, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1749398400000, receivedDateStr=2025-06-09, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793264185622, onlineDateStr=2026-10-29, pubDate=1764000000000, pubDateStr=2025-11-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793264185622, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793264185622, creator=13701087609, updateTime=1793264185622, updator=13701087609, issue=Issue{id=1322609030938346427, tenantId=1146029695717560320, journalId=1227665162245664772, year='2025', volume='52', issue='22', pageStart='4033', pageEnd='4224', issueExtLink='null', onlineDate='null', pubDate='1764000000000', pubDateStr='2025-11-25', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793264165863, creator='13701087609', updateTime=1793264299902, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322609593264489401, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1322609030938346427, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322609593264489402, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1322609030938346427, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=4175, endPage=4180, ext={EN=ArticleExt(id=1322609114031698346, articleId=1322609113813594537, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Evaluation of safety and efficacy of recombinant zoster vaccine in people over 50 years old, Nanchang City, columnId=1228016573156360233, journalTitle=Modern Preventive Medicine, columnName=Disease Control and Prevention, runingTitle=null, highlight=null, articleAbstract=
Objective

To evaluate the safety and efficacy of two doses of recombinant zoster vaccine（RZV）in normal immune population over 50 years of age in Nanchang.

Methods

1 802 people over 50 years old who received two doses of RZV were selected as the observation group, and 2 132 people were simultaneously inoculated with Pneumococcal Vaccine Polyvalent（PPV23）and Quadrivalent influenza vaccines（QIV）in subjects over 50 years of age served as a control group. The incidence of adverse reactions and the incidence of Herpes zoster（HZ）within 1 year after vaccination were analyzed and compared between the observation group and the control group after vaccination.

Results

In the observation group, the incidence of adverse reactions was 23.89%, the incidence of adverse reactions at inoculation site, abnormal vital signs and non-inoculation site were 16.79%, 9.05% and 7.69%, and the incidence of grade 1 and grade 2 adverse reactions were 22.42% and 1.47%. The incidence of adverse reactions in control group was 8.72%, the incidence of adverse reactions at inoculation site, abnormal vital signs and non-inoculation site were 7.38%, 2.06% and 1.17%, and the incidence of grade 1 and grade 2 adverse reactions were 7.60% and 1.13%. There were statistically significant differences in the incidence of adverse reactions between the observation group and the control group（χ2=187.817-339.938, P<0.05）, but there was no significant difference in the incidence of grade 2 adverse reactions（χ2=0.109-1.833, P>0.05）. Within one year after vaccination, the incidence of HZ was 0.33% in the observation group and 1.45% in the control group. The estimated vaccine effectiveness（VE）after two doses of RZV vaccine was 77.82%（95% CI:47.07%-90.70%）.

Conclusion

Two doses of RZV were highly effective. Although the incidence of adverse reactions is high but the degree is mild, it has a good safety.

, authors=Wei LUO, Ying-jiu YU, Zheng-bo TU, Jing WANG, authorsList=Wei LUO, Ying-jiu YU, Zheng-bo TU, Jing WANG, authorCompany=null, correspAuthors=Zheng-bo TU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322609115801694637, articleId=1322609113813594537, tenantId=1146029695717560320, journalId=1227665162245664772, language=CN, title=南昌市≥50岁人群接种重组带状疱疹疫苗的安全性和有效性评价, columnId=1228016573844226129, journalTitle=现代预防医学, columnName=疾病预防控制, runingTitle=null, highlight=null, articleAbstract=
目的

分析南昌市50岁以上人群全程接种两剂次带状疱疹重组亚单位疫苗（recombinant zoster vaccine，RZV）的安全性和有效性。

方法

将1 802名接种两剂次RZV的50岁以上者作为观察组，将2 132名同时接种23价肺炎球菌多糖疫苗（Pneumococcal Vaccine Polyvalent，PPV23）和四价流感病毒裂解疫苗（Quadrivalent influenza vaccines,QIV）的50岁以上者作为对照组，分析比较观察组和对照组疫苗接种后1年内的不良反应发生和带状疱疹（Herpes zoster，HZ）发病情况。

结果

观察组不良反应发生率为23.89%，接种部位不良反应、生命体征异常和非接种部位不良反应的发生率分别为16.79%、9.05%和7.69%，1级和2级不良反应发生率分别为22.42%和1.47%；对照组不良反应发生率为8.72%，接种部位不良反应、生命体征异常和非接种部位不良反应的发生率分别为7.38%、2.06%和1.17%，1级和2级不良反应发生率分别为7.60%和1.13%。观察组和对照组在各项不良反应发生率的差异具有统计学意义（χ2=187.817~339.938, P<0.05），但在2级不良反应发生率的差异不存在统计学意义（χ2=0.109~1.833, P>0.05）。接种疫苗后1年内观察组HZ发病率0.33%，对照组为1.45%， RZV疫苗接种2剂次后的免疫效果（vaccine effectiveness，VE）为77.82%（95% CI:47.07%~90.70%）。

结论

接种两剂次RZV疫苗后预防带状疱疹免疫效果较好，其不良反应发生率较高但程度较轻，仍具有较好的安全性。

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罗威（1971—），男，本科，主任医师，研究方向：免疫规划和预防接种工作

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涂正波，E-mail:
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Chinese Journal of Epidemiology, 2023, 44 (6): 899-904.（In Chinese）, articleTitle=A study on knowledge, attitude, and vaccination behavior of herpes zoster vaccine among urban residents in selected areas of China, refAbstract=null), Reference(id=1322609122944594421, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, doi=null, pmid=null, pmcid=null, year=2024, volume=25, issue=2, pageStart=222, pageEnd=227, url=null, language=null, rfNumber=[19], rfOrder=31, authorNames=王小龙, 张恩铭, 戴正悦, journalName=中国预防医学杂志, refType=null, unstructuredReference=王小龙，张恩铭，戴正悦, 等. 上海市老年人带状疱疹疫苗犹豫现状及影响因素 [J]. 中国预防医学杂志, 2024, 25 (2): 222-227., articleTitle=上海市老年人带状疱疹疫苗犹豫现状及影响因素, refAbstract=null), Reference(id=1322609123028480502, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, doi=null, pmid=null, pmcid=null, year=2024, volume=25, issue=2, pageStart=222, pageEnd=227, url=null, language=null, rfNumber=[19], rfOrder=32, authorNames=Wang XL, Zhang EM, Dai ZY, journalName=China Preventive Medicine, refType=null, unstructuredReference=Wang XL, Zhang EM, Dai ZY, et al. 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China Preventive Medicine, 2024, 25 (2): 222-227.（In Chinese）, articleTitle=Study on the current situation and influencing factors of herpes zoster vaccine hesitation among elderly in Shanghai, refAbstract=null), Reference(id=1322609123095589367, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, doi=null, pmid=null, pmcid=null, year=2024, volume=22, issue=1, pageStart=227, pageEnd=232, url=null, language=null, rfNumber=[20], rfOrder=33, authorNames=华敏凡, 宋沧桑, 李兴德, journalName=中南药学, refType=null, unstructuredReference=华敏凡，宋沧桑，李兴德, 等. 佐剂重组带状疱疹疫苗用于50岁以上人群的快速卫生技术评估 [J]. 中南药学, 2024, 22 (1): 227-232., articleTitle=佐剂重组带状疱疹疫苗用于50岁以上人群的快速卫生技术评估, refAbstract=null), Reference(id=1322609123171086840, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, doi=null, pmid=null, pmcid=null, year=2024, volume=22, issue=1, pageStart=227, pageEnd=232, url=null, language=null, rfNumber=[20], rfOrder=34, authorNames=Hua MF, Song CS, Li XD, journalName=Central South Pharmacy, refType=null, unstructuredReference=Hua MF, Song CS, Li XD, et al. Rapid health technology assessment of adjuvanted recombinant herpes zoster vaccine in People over 50 years old [J]. Central South Pharmacy, 2024, 22 (1): 227-232.（In Chinese）, articleTitle=Rapid health technology assessment of adjuvanted recombinant herpes zoster vaccine in People over 50 years old, refAbstract=null), Reference(id=1322609123246584313, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, doi=null, pmid=null, pmcid=null, year=2024, volume=12, issue=8, pageStart=935, pageEnd=null, url=null, language=null, rfNumber=[21], rfOrder=35, authorNames=Zhu Z, Sun J, Xie Y, journalName=Vaccines, refType=null, unstructuredReference=Zhu Z, Sun J, Xie Y, et al. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine administered concomitantly with a 23-Valent pneumococcal polysaccharide vaccine in adults aged 60 years and older [J]. Vaccines, 2024, 12 (8): 935., articleTitle=Immunogenicity and safety of an inactivated quadrivalent influenza vaccine administered concomitantly with a 23-Valent pneumococcal polysaccharide vaccine in adults aged 60 years and older, refAbstract=null), Reference(id=1322609123368219130, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, doi=null, pmid=null, pmcid=null, year=2024, volume=20, issue=1, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[22], rfOrder=36, authorNames=Pang X, Spence O, Parmar N, journalName=Human Vaccines & Immunotherapeutics, refType=null, unstructuredReference=Pang X, Spence O, Parmar N, et al. A prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the recombinant zoster vaccine in Chinese adults≥50 years of age [J]. 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Annals of Internal Medicine, 2024, 177 (2): 189-195., articleTitle=Effectiveness of recombinant zoster vaccine against herpes zoster in a Real-World setting, refAbstract=null), Reference(id=1322609123548574204, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, doi=null, pmid=null, pmcid=null, year=2025, volume=25, issue=1, pageStart=985, pageEnd=null, url=null, language=null, rfNumber=[24], rfOrder=38, authorNames=Ohfuji S, Toyama N, Kondo K, journalName=BMC Infectious Diseases, refType=null, unstructuredReference=Ohfuji S, Toyama N, Kondo K, et al. Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in Japan [J]. BMC Infectious Diseases, 2025, 25 (1): 985., articleTitle=Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in Japan, refAbstract=null), Reference(id=1322609123607294461, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, doi=null, pmid=null, pmcid=null, year=2015, volume=2, issue=suppl1, pageStart=1927, pageEnd=null, url=null, language=null, rfNumber=[25], rfOrder=39, authorNames=C LA, Roman C, Javier D, journalName=Open Forum Infect Dis, refType=null, unstructuredReference=C LA, Roman C, Javier D, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults by region: results of the phase 3 ZOE-50 trial [J]. Open Forum Infect Dis, 2015, 2 (suppl1): 1927., articleTitle=Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults by region: results of the phase 3 ZOE-50 trial, refAbstract=null), Reference(id=1322609123670209022, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, doi=null, pmid=null, pmcid=null, year=2019, volume=15, issue=12, pageStart=2865, pageEnd=2872, url=null, language=null, rfNumber=[26], rfOrder=40, authorNames=Oostvogels L, Heineman TC, Johnson RW, journalName=Human Vaccines & Immunotherapeutics, refType=null, unstructuredReference=Oostvogels L, Heineman TC, Johnson RW, et al. Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials [J]. Human Vaccines & Immunotherapeutics, 2019, 15 (12): 2865-2872., articleTitle=Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials, refAbstract=null)], funds=[Fund(id=1322609118662210005, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, awardId=202211687, language=CN, fundingSource=江西省卫生健康委科技项目(202211687), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1322609116279845294, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, xref=null, ext=[AuthorCompanyExt(id=1322609116288233903, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, companyId=1322609116279845294, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=The Collaboration Unit of Field Epidemiology of State Key Laboratory for Infectious Disease Prevention and Control, Jiangxi Provincial Key Laboratory of Animal-origin and Vector-borne Diseases, Nanchang Center for Disease Control and Prevention, Nanchang, Jiangxi 330038, China), AuthorCompanyExt(id=1322609116300816816, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, companyId=1322609116279845294, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=传染病预防控制国家重点实验室研究基地，江西省动物源与媒介生物性传染病重点实验室，南昌市疾病预防控制中心，江西　南昌，330038)])], figs=[ArticleFig(id=1322609118020481485, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, language=EN, label=Table 1, caption=

Comparison ofadverse reactions between observation group and control group

, figureFileSmall=null, figureFileBig=null, tableContent=
观察项目观察组（n=3 604）对照组（n=4 264）χ2P
剂次数
cases		发生率
Incidence		剂次数
cases		发生率
Incidence
全部不良反应86123.893728.72339.938<0.001
接种部位不良反应60516.793157.38167.119<0.001
疼痛、触痛47013.042826.6193.348<0.001
硬结、肿胀2456.80611.43150.536<0.001
皮疹、红晕1072.97481.1334.361<0.001
接种处瘙痒681.89240.5629.625<0.001
生命体征异常3269.05882.06190.986<0.001
发热3269.05882.06190.986<0.001
非接种部位不良反应2777.69501.17187.817<0.001
胃肠道不适551.53180.4218.231<0.001
肌肉痛2025.6060.14226.581<0.001
其它部位瘙痒481.3380.1936.187<0.001
急性荨麻疹240.67100.238.4480.004
头痛1052.9160.14107.959<0.001
疲劳乏力2286.33120.28246.335<0.001
), ArticleFig(id=1322609118112756174, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, language=CN, label=表1, caption=

观察组和对照组不良反应发生情况比较

, figureFileSmall=null, figureFileBig=null, tableContent=
观察项目观察组（n=3 604）对照组（n=4 264）χ2P
剂次数
cases		发生率
Incidence		剂次数
cases		发生率
Incidence
全部不良反应86123.893728.72339.938<0.001
接种部位不良反应60516.793157.38167.119<0.001
疼痛、触痛47013.042826.6193.348<0.001
硬结、肿胀2456.80611.43150.536<0.001
皮疹、红晕1072.97481.1334.361<0.001
接种处瘙痒681.89240.5629.625<0.001
生命体征异常3269.05882.06190.986<0.001
发热3269.05882.06190.986<0.001
非接种部位不良反应2777.69501.17187.817<0.001
胃肠道不适551.53180.4218.231<0.001
肌肉痛2025.6060.14226.581<0.001
其它部位瘙痒481.3380.1936.187<0.001
急性荨麻疹240.67100.238.4480.004
头痛1052.9160.14107.959<0.001
疲劳乏力2286.33120.28246.335<0.001
), ArticleFig(id=1322609118179865039, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, language=EN, label=Table 2, caption=

Comparison of severity of adverse reactions between observation group and control group

, figureFileSmall=null, figureFileBig=null, tableContent=
观察项目观察组（n=3 604）对照组（n=4 264）χ2P
剂次数
cases		发生率
Incidence（%）		剂次数
cases		发生率
Incidence（%）
接种部位不良反应60516.793156.75167.119<0.001
1级反应58016.092880.63173.560<0.001
2级反应250.69270.560.1090.742
生命体征异常3269.05882.06190.986<0.001
1级反应3058.46711.67198.338<0.001
2级反应210.58170.401.3760.241
非接种部位不良反应2777.69501.17187.817<0.001
1级反应2657.35420.98211.226<0.001
2级反应120.3380.191.6270.202
全部不良反应86123.893728.72339.938<0.001
1级反应80822.423247.60348.712<0.001
2级反应531.47481.131.8330.176
), ArticleFig(id=1322609118263751120, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, language=CN, label=表2, caption=

观察组和对照组不良反应严重程度比较

, figureFileSmall=null, figureFileBig=null, tableContent=
观察项目观察组（n=3 604）对照组（n=4 264）χ2P
剂次数
cases		发生率
Incidence（%）		剂次数
cases		发生率
Incidence（%）
接种部位不良反应60516.793156.75167.119<0.001
1级反应58016.092880.63173.560<0.001
2级反应250.69270.560.1090.742
生命体征异常3269.05882.06190.986<0.001
1级反应3058.46711.67198.338<0.001
2级反应210.58170.401.3760.241
非接种部位不良反应2777.69501.17187.817<0.001
1级反应2657.35420.98211.226<0.001
2级反应120.3380.191.6270.202
全部不良反应86123.893728.72339.938<0.001
1级反应80822.423247.60348.712<0.001
2级反应531.47481.131.8330.176
), ArticleFig(id=1322609118351831505, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, language=EN, label=Table 3, caption=

The occurrence time and duration of adverse reactions were compared between the observation group and the control group

, figureFileSmall=null, figureFileBig=null, tableContent=
观察项目观察组（n=86）对照组（n=372）χ2P
剂次数
cases		发生率
Incidence		剂次数
cases		发生率
Incidence
发生时间2.2020.532
<30 min11913.824211.29
30 min~24 h68479.4430682.26
第2~3天485.57184.84
第4~7天101.1661.61
持续时间4.4920.213
≤1天789.06308.06
2~3天46954.4722660.75
4~7天25829.979826.34
>7天566.50184.84
), ArticleFig(id=1322609118414746066, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, language=CN, label=表3, caption=

观察组和对照组不良反应出现时间和持续时间比较

, figureFileSmall=null, figureFileBig=null, tableContent=
观察项目观察组（n=86）对照组（n=372）χ2P
剂次数
cases		发生率
Incidence		剂次数
cases		发生率
Incidence
发生时间2.2020.532
<30 min11913.824211.29
30 min~24 h68479.4430682.26
第2~3天485.57184.84
第4~7天101.1661.61
持续时间4.4920.213
≤1天789.06308.06
2~3天46954.4722660.75
4~7天25829.979826.34
>7天566.50184.84
), ArticleFig(id=1322609118490243539, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, language=EN, label=Table 4, caption=

Comparison of the incidence of Herpes zoster（HZ）between observation group and control group

, figureFileSmall=null, figureFileBig=null, tableContent=
年龄组观察组对照组χ2PVE
（95% CI）（%）
观察数HZ例数HZ发病率观察数HZ例数HZ发病率
50~641 16730.261 414191.348.933<0.00180.87（35.89~94.3）
≥6563530.47718131.815.1640.02373.91（8.85~92.53）
合计1 80260.332 132321.5013.927<0.00177.82（47.07~90.70）
), ArticleFig(id=1322609118557352404, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1322609113813594537, language=CN, label=表4, caption=

观察组和对照组HZ发病情况比较

, figureFileSmall=null, figureFileBig=null, tableContent=
年龄组观察组对照组χ2PVE
（95% CI）（%）
观察数HZ例数HZ发病率观察数HZ例数HZ发病率
50~641 16730.261 414191.348.933<0.00180.87（35.89~94.3）
≥6563530.47718131.815.1640.02373.91（8.85~92.53）
合计1 80260.332 132321.5013.927<0.00177.82（47.07~90.70）
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南昌市≥50岁人群接种重组带状疱疹疫苗的安全性和有效性评价
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罗威 , 喻迎九 , 涂正波 , 王菁
现代预防医学 | 疾病预防控制 2025,52(22): 4175-4180
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现代预防医学 |疾病预防控制 2025 , 52 (22) : 4175 -4180
南昌市≥50岁人群接种重组带状疱疹疫苗的安全性和有效性评价
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罗威, 喻迎九, 涂正波 , 王菁
作者信息
  • 传染病预防控制国家重点实验室研究基地，江西省动物源与媒介生物性传染病重点实验室，南昌市疾病预防控制中心，江西　南昌，330038
通讯作者:
涂正波，E-mail:
作者简介:

罗威（1971—），男，本科，主任医师，研究方向：免疫规划和预防接种工作

Evaluation of safety and efficacy of recombinant zoster vaccine in people over 50 years old, Nanchang City
Wei LUO, Ying-jiu YU, Zheng-bo TU , Jing WANG
Affiliations
  • The Collaboration Unit of Field Epidemiology of State Key Laboratory for Infectious Disease Prevention and Control, Jiangxi Provincial Key Laboratory of Animal-origin and Vector-borne Diseases, Nanchang Center for Disease Control and Prevention, Nanchang, Jiangxi 330038, China
出版时间: 2025-11-25 doi: 10.20043/j.cnki.MPM.202506149
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摘要
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目的

分析南昌市50岁以上人群全程接种两剂次带状疱疹重组亚单位疫苗（recombinant zoster vaccine，RZV）的安全性和有效性。

方法

将1 802名接种两剂次RZV的50岁以上者作为观察组，将2 132名同时接种23价肺炎球菌多糖疫苗（Pneumococcal Vaccine Polyvalent，PPV23）和四价流感病毒裂解疫苗（Quadrivalent influenza vaccines,QIV）的50岁以上者作为对照组，分析比较观察组和对照组疫苗接种后1年内的不良反应发生和带状疱疹（Herpes zoster，HZ）发病情况。

结果

观察组不良反应发生率为23.89%，接种部位不良反应、生命体征异常和非接种部位不良反应的发生率分别为16.79%、9.05%和7.69%，1级和2级不良反应发生率分别为22.42%和1.47%；对照组不良反应发生率为8.72%，接种部位不良反应、生命体征异常和非接种部位不良反应的发生率分别为7.38%、2.06%和1.17%，1级和2级不良反应发生率分别为7.60%和1.13%。观察组和对照组在各项不良反应发生率的差异具有统计学意义（χ2=187.817~339.938, P<0.05），但在2级不良反应发生率的差异不存在统计学意义（χ2=0.109~1.833, P>0.05）。接种疫苗后1年内观察组HZ发病率0.33%，对照组为1.45%， RZV疫苗接种2剂次后的免疫效果（vaccine effectiveness，VE）为77.82%（95% CI:47.07%~90.70%）。

结论

接种两剂次RZV疫苗后预防带状疱疹免疫效果较好，其不良反应发生率较高但程度较轻，仍具有较好的安全性。

带状疱疹  /  重组带状疱疹疫苗  /  不良反应  /  免疫效果
Objective

To evaluate the safety and efficacy of two doses of recombinant zoster vaccine（RZV）in normal immune population over 50 years of age in Nanchang.

Methods

1 802 people over 50 years old who received two doses of RZV were selected as the observation group, and 2 132 people were simultaneously inoculated with Pneumococcal Vaccine Polyvalent（PPV23）and Quadrivalent influenza vaccines（QIV）in subjects over 50 years of age served as a control group. The incidence of adverse reactions and the incidence of Herpes zoster（HZ）within 1 year after vaccination were analyzed and compared between the observation group and the control group after vaccination.

Results

In the observation group, the incidence of adverse reactions was 23.89%, the incidence of adverse reactions at inoculation site, abnormal vital signs and non-inoculation site were 16.79%, 9.05% and 7.69%, and the incidence of grade 1 and grade 2 adverse reactions were 22.42% and 1.47%. The incidence of adverse reactions in control group was 8.72%, the incidence of adverse reactions at inoculation site, abnormal vital signs and non-inoculation site were 7.38%, 2.06% and 1.17%, and the incidence of grade 1 and grade 2 adverse reactions were 7.60% and 1.13%. There were statistically significant differences in the incidence of adverse reactions between the observation group and the control group（χ2=187.817-339.938, P<0.05）, but there was no significant difference in the incidence of grade 2 adverse reactions（χ2=0.109-1.833, P>0.05）. Within one year after vaccination, the incidence of HZ was 0.33% in the observation group and 1.45% in the control group. The estimated vaccine effectiveness（VE）after two doses of RZV vaccine was 77.82%（95% CI:47.07%-90.70%）.

Conclusion

Two doses of RZV were highly effective. Although the incidence of adverse reactions is high but the degree is mild, it has a good safety.

Herpes zoster  /  Recombinant zoster vaccine  /  Adverse reaction  /  Vaccine effectiveness
罗威, 喻迎九, 涂正波, 王菁. 南昌市≥50岁人群接种重组带状疱疹疫苗的安全性和有效性评价. 现代预防医学, 2025 , 52 (22) : 4175 -4180 . DOI: 10.20043/j.cnki.MPM.202506149
Wei LUO, Ying-jiu YU, Zheng-bo TU, Jing WANG. Evaluation of safety and efficacy of recombinant zoster vaccine in people over 50 years old, Nanchang City[J]. Modern Preventive Medicine, 2025 , 52 (22) : 4175 -4180 . DOI: 10.20043/j.cnki.MPM.202506149
正文
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带状疱疹（Herpes zoster，HZ）是由长期潜伏在脊髓后跟神经节或颅神经节中的水痘-带状疱疹病毒（Varicella-zoster virus，VZV）在宿主免疫功能下降时再次激活引起的感染性皮肤病，其在50岁及以上或免疫力低下的人群中高发，且发病风险随着年龄的增长而增加[1]。HZ常并发感染性神经痛（Post-herpetic neuralgia，PHN），严重影响病例生活质量，造成了严重的社会经济负担[2]。接种带状疱疹疫苗（herpes zoster vaccine，HZV）是预防HZ的关键措施，目前国内使用的HZV包括带状疱疹减毒活疫苗（zoster vaccine live，ZVL）和重组带状疱疹疫苗 （recombinant zoster vaccine，RZV）[3]，分别于2023年和2020年批准上市。其中RZV因不具备毒性和致病性，在国内不仅适用于50 岁及以上免疫功能正常者预防HZ，而且慢性病患者（如慢性阻塞性肺病、慢性肾功能衰竭、糖尿病）和免疫力低下人群（如肿瘤患者、移植受者、HIV感染者）等也可以接种[4]。对于RZV疫苗在我国适龄人群接种安全性评价，国内北京、广东已有研究报道[5-6]，但研究结果存在较大的差异，而针对RZV疫苗有效性的研究国内则罕有报道。本研究通过对江西省南昌市≥50岁人群全程接种RZV疫苗后的不良反应发生和HZ发病情况进行随访观察，对RZV疫苗有效性和安全性进行评估，为HZ的免疫预防提供参考依据。
1　材料与方法
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1.1　调查对象入组和样本量估算
在南昌市红谷滩区预防医学门诊选择2021年1月1日—2023年12月31日完成相关疫苗接种的所有人员，纳入标准：接种疫苗时≥50岁，既往免疫功能正常。排除标准：①随访期间服用激素或免疫抑制剂者；②慢性病急性发作者；③随访期间接种过其它疫苗者；④非疫苗原因导致不能完成全程随访者。研究对象按照接种意愿分为观察组和对照组。根据计算公式n1=n2=1 ，查询相关疫苗安全性研究数据[7-8]，设定P1=0.001, P2=0.010，uα=1.96，uβ=1.282，估计失访率为10%，观察组和对照组最小样本量均为780人。本研究已通过南昌市疾病预防控制中心伦理审核委员会审核批准，批准号[2021]第12号。
1.2　疫苗接种
观察组在6个月内全程接种两剂次RZV，接种间隔时间≥2个月，每剂次0.5 ml，于上臂外侧三角肌注射，RZV为 GSK生产。对照组则同时接种1剂次4价流感病毒裂解疫苗（单剂次0.5 ml，于右上臂外侧三角肌注射，疫苗为华兰生物或北京科兴生产）与23价肺炎球菌多糖疫苗（单剂次0.5ml，于左上臂外侧三角肌注射，疫苗为MSD生产）各一剂。
1.3　接种后不良反应和HZ发病随访
在两组研究对象接种疫苗前，收集研究对象的年龄、性别HZ患病史、水痘患病史、过敏或其他免疫疾病史。观察组和对照组的不良反应发生情况都在相应疫苗接种的30分钟和第2、3、7、15和28天后进行调查，除接种疫苗后30分钟为面对面调查，其余为接受电话询问；观察组和对照组在完成相关疫苗接种后的1年内，每月接受电话询问，调查随访期内HZ发病情况。
1.3.1　接种后不良反应
为与疫苗接种相关的任何不良反应或者意外事件，按照国家药品监督管理局2019年印发的《预防用疫苗临床试验不良事件分级标准指导原则》[9]，按接种部位（包括疼痛、硬结、肿胀、皮疹、瘙痒、蜂窝组织炎等）、生命体征（包括发热、心电图改变、心率改变、血压改变和呼吸频率改变等）、非接种部位（包括胃肠道症状、肌肉痛、急性荨麻疹、头痛、乏力等）、实验室检测指标（血液生化、血液常规、尿液常规等）不良事件/反应的严重程度，由轻至重分为1级（不影响日常活动）、2级（稍影响正常活动）、3级（严重影响日常活动）和4 级（需门诊或住院治疗）。
1.3.2　HZ发病
按照《中国带状疱疹诊疗专家共识》[10]，HZ的诊断依据为典型皮损表现（沿皮节单侧分布的成簇性水疱，沿某一周围神经区域呈带状排列）和自觉症状（疱疹相关性疼痛、瘙痒等）。
1.4　研究质量控制
研究前设计统一的调查问卷，随访后调查问卷采取双人录入方式录入数据库，并对关键变量审核和逻辑检查，剔除关键变量存在错误和缺失的调查问卷。对随访期内所有出现不良反应和HZ的研究对象以及随机抽取的5%未出现不良反应和HZ的研究对象进行电话复核，分析不良反应与试验疫苗的关联性，剔除与疫苗接种无关的异常表现。
1.5　统计分析
使用EXCEL 2010软件建立数据库，使用SPSS 25.0统计软件分析随访期内观察组和对照组疫苗接种后不良反应发生率和HZ发病率，计算RZV疫苗免疫效果（vaccine effectiveness，VE）及其95%置信区间（Confidence interval，CI），不良反应发生率=随访期发生不良反应的接种剂次数/疫苗接种总剂次数×100%。HZ发病率=随访期间HZ发病例数/研究对象例数×100%，相对危险度（Relative risk，RR）=观察组HZ发病率/对照组HZ发病率，VE=（1-RR）×100%[11]。两组不良反应发生率的比较采用χ2检验，检验水准α=0.05。
2　结果
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2.1　基本情况
经质量审核后，观察组和对照组完成调查和随访的研究对象分别为1 802人和2 132人，分别完成3 604和4 264剂次疫苗接种，满足样本量要求。其中，观察组男性727人，女性1 075人，年龄分布为61.97±5.76岁，对照组男性869人，女性1 263人，年龄分布为60.93±6.28，观察组和对照组在性别（χ2=0.070，P=0.791）和年龄（t=1.281, P=0.200）分布上的差异无统计学意义。
2.2　疫苗安全性分析
2.2.1　总体情况
在随访期中，观察组中有522人接种861剂次后出现不良反应，不良反应发生率23.89%。观察组中有605剂次为接种部位不良反应、326剂次为生命体征异常、277剂次为非接种部位不良反应，发生率分别为16.79%、9.05%和7.69%。对照组中186人完成372剂次接种后出现不良反应，不良反应发生率8.72%，其中315剂次为接种部位不良反应、88剂次为生命体征异常、50剂次接种后出现非接种部位不良反应，发生率分别为7.38%、2.06%和1.17%。经比较，观察组和对照组各项不良反应发生率的差异均存在统计学意义（P<0.05），详见表1。
2.2.2　严重程度
两组均未观察到2级以上的不良反应，观察组的不良反应包括808剂次的1级和53剂次2级事件，1级和2级不良反应发生率分别为22.42%和1.47%。对照组的不良反应包括324剂次的1级事件和48剂次的2级事件，1级和2级不良反应发生率分别为7.60%和1.13%。经比较，两组在1级不良反应发生率的差异均存在统计学意义（P<0.05），但在2级不良反应发生率的差异不存在统计学意义（P>0.05），详见表2。
2.2.3　出现时间和转归
两组研究对象出现的不良反应，均出现在接种疫苗7天内，持续时间也多在7天内，无加重、后遗症、死亡等转归出现。比较观察组和对照组不良反应出现时间和持续时间的分布，其差异均无统计学意义（P>0.05），详见表3。
2.3　疫苗有效性分析
随访中，观察组观察到6例HZ病例，发病率为0.33%，对照组观察到32例HZ病例，发病率为1.50%。经比较，观察组和对照组在各年龄段的HZ发病率存在的差异均具有统计学意义（均P<0.05）。推算50岁以上人群接种两剂次RZV疫苗的VE为77.82%（95% CI:47.07%~90.70%），其中50~64岁年龄段人群接种两剂次RZV疫苗的VE为80.87%（95% CI:35.89%~94.32%），65岁及以上年龄段人群接种两剂次RZV疫苗1年内的VE为73.91%（95% CI:8.85%~92.53%）。详见表4。
3　讨论
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HZ主要表现为沿感觉神经呈单侧分布的皮疹，同时常出现累及神经系统和眼部的并发症或后遗症，如持续时间长、疼痛程度剧烈的PHN，以及Ramsay-Hunt 综合征、Bell面瘫、脑膜炎、脊髓炎等[12]。同时，HZ流行广泛，目前国内报道的HZ发病率与其他国家相近，多在0.19/千人年~10.4/千人年之间[13]，在50岁以上人群中HZ发病率随年龄逐步上升，至80岁时可达10.9 /千人年[14]，且HZ复发率接近10%[15]。随着我国人口老龄化程度加深，HZ高发已成为国内一个严重的公共卫生问题，预防老年人罹患HZ显得尤为重要。2018年RZV疫苗在国外被许可用于预防HZ[16]，并于2020年获准在中国上市。目前国内RZV疫苗接种率和接种意愿较低[17-18]。而对疫苗安全性和有效性缺乏信心，是国内老年人对接种包括RZV疫苗在内的HZV疫苗产生犹豫甚至拒绝的主要原因[19]。因此，对RZV疫苗在国内使用的有效性、安全性等方面进行的全面系统地评价[20]，对促进通过RZV疫苗防控国内HZ流行具有重要意义。
目前，在老年人中同时接种PPV 23疫苗与QIV疫苗已获得较高的安全性评价[21]。本研究中，将同时接种上述两种疫苗的50岁及以上的老年人作为对照组，将同期同年龄段全程接种RZV疫苗者作为观察组，通过对接种后的随访观察，结果发现观察组疫苗接种后不良反应虽高于对照组，但大多数为轻度不良反应，表明RZV疫苗仍具有较好的安全性。此次研究中，全程接种RZV疫苗者的不良反应发生率低于北京市的观察数据（66.34%）[5]，但远高于广东省（196.65/10万）[6] ，推测调查数据低于前者的原因可能是北京市研究对象较少（303人），而高于后者则可能是广东省的研究数据来自于疑似预防接种异常反应信息管理系统，属于对因不良反应就医者的被动监测，敏感性较低。同时，观察组出现的疫苗接种后不良反应主要为接种处部位的肿痛、全身发热和非接种部位的肌肉痛。上述不良反应均在接种后7天内发生，持续时间多在7天以内，这和对照组基本无差异，也和国内外报道的RZV疫苗接种后不良反应的特征[5-6,22]基本一致。
本研究同时发现，RZV疫苗在50岁以上人群全程接种后的1年内VE和Zerbo等[23]通过前瞻性队列研究结果（79%，95% CI: 77%~81%）基本相同，也较接近Ohfuji等[24]回顾性队列研究结果（85%），但低于RZV疫苗上市前临床试验测试结果（97.2%，95% CI: 94%~99%）[25]。分析测试结果出现差距的原因，可能是本次随访观察中，没有如上市前临床试验采用PCR检测来判断受试对象是否感染VZV，可能会漏诊亚临床或症状轻微的HZ病例，从而影响HZ发病率的观测值。另外，本研究还发现，65岁以上人群和50-64岁人群接种RZV疫苗后的VE差距较小，这也和Oostvogels等[26]调查得出RZV疫苗免疫效果并不随老年人虚弱程度的增加而明显下降的结论相吻合。
综上所述，RZV疫苗接种后能够有效预防50岁以上人群感染HZ，其不良反应发生率虽较高但程度多较轻，仍具有较好的安全性。为降低HZ发病率，应采取措施促进老年人接种疫苗。同时，对RZV疫苗接种后可能出现的不良反应，做好解释和跟踪随访，及时消除接种者的疑虑。
基金
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  • 江西省卫生健康委科技项目(202211687)
文献
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2025年第52卷第22期
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doi: 10.20043/j.cnki.MPM.202506149
  • 接收时间：2025-06-09
  • 首发时间：2026-10-29
  • 出版时间：2025-11-25
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  • 收稿日期：2025-06-09
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江西省卫生健康委科技项目(202211687)
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    传染病预防控制国家重点实验室研究基地，江西省动物源与媒介生物性传染病重点实验室，南昌市疾病预防控制中心，江西　南昌，330038

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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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